A Clinical Evaluation of a Vaginal Bowel Control System for the Treatment of Fecal Incontinence in Women (LIFE) (LIFE)

May 22, 2015 updated by: Pelvalon, Inc.

A Clinical Evaluation of the LivSure Vaginal Bowel Control (VBC) System for the Treatment of Fecal Incontinence in Women.

The objective of this study is to obtain preliminary efficacy and safety data on the use of the LivSure System (now called the "Eclipse™ System") in women with fecal incontinence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • History of FI for at least 6 months
  • Baseline diary requirement for min # of FI episodes in a two-week period
  • Ability to manage investigational device insertion and removal
  • Successful fitting of study device
  • Willing and able to give written informed consent to participate in the study

Exclusion Criteria:

  • Chronic rectal, anal or pelvic pain
  • Any vaginal prolapse that extends beyond the plane of the hymen.
  • Previous rectal or pelvic floor surgery within the last 12 months (24 months in the case of cancer)
  • Congenital anorectal malformation
  • Chronic watery diarrhea unmanageable by drugs or diet as primary cause of FI
  • Inflammatory bowel disease
  • Presence of a vaginal, anal, rectal or urethral fistula or anastomosis
  • Presence of a vaginal, rectal or bladder tumor
  • Presence of an open wound or tear in the vagina or anus by exam
  • Presence or history of rectovaginal fistula
  • Atrophic vaginal tissue as determined by symptoms or visualization
  • Current vaginal or urinary infection requiring treatment
  • History of recurrent urinary or vaginal infections
  • Subject is currently pregnant or planning pregnancy in next 5 months
  • Concurrent use of any intra-vaginal device that would interfere with LivSure (now called Eclipse) placement or wearing
  • Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.) or other factor that the investigator believes would interfere with study participation and/or increase subject risk

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Vaginal Bowel Control
A vaginal bowel control system intended to manage fecal incontinence.
Device: vaginal bowel control system (LivSure)
Other Names:
  • LivSure System
  • Eclipse™ System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of FI Episodes
Time Frame: 1 Month
Subjects with at least a 50% reduction in FI episodes (major or minor soiling)
1 Month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Incontinent Days
Time Frame: 1 Month
Change in number of incontinent days while wearing the device during the 2-week assessment period as compared to the baseline 2-week assessment period
1 Month
Device-related Adverse Events
Time Frame: 1month
The number of overall adverse events rated as probably or definitely related to the study device.
1month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pelvalon, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ACTUAL)

January 1, 2014

Study Completion (ACTUAL)

March 1, 2014

Study Registration Dates

First Submitted

July 24, 2012

First Submitted That Met QC Criteria

August 1, 2012

First Posted (ESTIMATE)

August 2, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 27, 2015

Last Update Submitted That Met QC Criteria

May 22, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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